COLLABORATIVE STUDIES ON ALZHEIMER'S DISEASE AND OTHER NEURODEGENERATIVE
DISEASES ASSOCIATED WITH AGING
RELEASE DATE: December 19, 2002
RFA: AG-03-005
National Institute on Aging (NIA)
(http://www.nih.gov/nia/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov/)
LETTER OF INTENT RECEIPT DATE: February 12, 2003
APPLICATION RECEIPT DATE: March 12, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this RFA is to facilitate collaborative cross-
disciplinary and multi-institutional approaches that will contribute
new and vital information about the clinical and pathological course of
normal aging and the neurodegenerative diseases associated with aging.
This RFA requires the utilization of data and/or samples from at least
three currently funded NIA Alzheimer's Disease Centers with the
possibility of using additional relevant data outside of the Centers.
The project should use the National Alzheimer's Coordinating Center
(NACC) http://www.alz.washington.edu/ for expert advice on planning,
study design, statistical analysis and data management of the research
projects. Applicants can be from the Alzheimer's Disease Centers, the
Morris K. Udall Centers, or the research community at large. There must
be a plan to share data originating from these studies by archiving
them at NACC so that other investigators will be able to conduct
additional analyses when appropriate. There must also be a plan for
sample utilization beyond that of the initial application.
This is a research opportunity for scientists within and outside the
Alzheimer's Disease Centers to gain access to unique resources related
to Alzheimer's Disease, other neurodegenerative diseases, and normal
aging and to support collection of new data and samples. Applicants can
also propose to utilize Center data and samples to investigate other
age-related neurodegenerative diseases, such as Vascular dementia,
Parkinson's dementia, Lewy Body disease, Fronto-Temporal dementia, as
well as study psychiatric symptoms associated with dementia, socio—
behavioral aspects of dementia, and management and care of dementia
patients.
The National Institute of Neurological Disorders and Stroke (NINDS) is
interested in those specific applications which include the Morris K.
Udall Centers of Excellence, or other Parkinson's research centers, in
the pursuit of those research objectives focused on Parkinson's Disease
(PD) or related parkinsonisms. The PD center need not be located with
ADCs, but collaboration with those ADCs with existing samples and data
sets focused on PD is required. Specific scientific projects of
interest include the use of clinico-pathological correlations to study
mechanisms of pathogenesis in PD or other parkinsonian conditions,
characterization of the pathological features of these conditions, and
the collection of patient data on their associated symptoms.
RESEARCH OBJECTIVES
Background
As research on Alzheimer's disease (AD) has matured, new aspects of the
disease are being addressed. More emphasis is being placed on the
clinical and neuropathological changes that distinguish the initial
stages of AD from normal aging. Also, as other neurodegenerative
diseases, such as Vascular dementia, Parkinson's disease, Lewy Body
disease, and Fronto-temporal dementia have features that overlap or
coexist with AD, some research could focus on collecting diagnostic
information that allows differentiation among the various diseases
while documenting analogous features. Using the large subject pool
enrolled at the Alzheimer's Disease Centers, larger scale multisite
collaborative studies are feasible to study successful aging, normal
aging, mild cognitive impairment (MCI) and mild AD. It is expected that
access to larger data sets through data pooling will increase
statistical power and permit characterization of the rarer and mixed
phenotypes among the various diseases. Further, it may be possible to
detect potential biomarkers or patterns that will help identify persons
at risk for disease, characterize and diagnose the different disease
entities, refine description of disease course, and monitor response to
treatment in different subsets of AD and other patients e.g. genetic
subsets, ethnic minorities, the oldest old, or those with less common
neurodegenerative diseases.
The NIA Alzheimer's Disease Centers (ADCs) program is authorized by the
Public Health Service Act, Section 445, and includes seventeen
Alzheimer's Disease Research Centers (ADRCs) and twelve Alzheimer's
Disease Core Centers (ADCCs). The Alzheimer's Centers have provided a
platform for the growth of research and training of scientists for AD
research and have been the leaders in research on clinico-pathological
correlations to compare normal aging and AD as well as in answering
many basic research questions on AD and related dementias. The main
function of the ADCs is to support cutting-edge research either
directly or indirectly by providing well-characterized patients and
family information and tissue and other biological specimens from
persons with AD and from age-matched control subjects for various
projects.
The National Alzheimer's Coordinating Center (NACC)
http://www.alz.washington.edu/ was established to collect a common data
set from all NIA funded Alzheimer's Disease Centers in order to
facilitate collaboration among the Alzheimer's Disease Centers on
important unanswered questions pertaining to AD, related disorders, and
normal aging. The database consists of several datasets.
Objectives
This RFA invites studies that utilize existing samples and data
gathered by the Centers and/or studies that collect additional data and
samples within the Center network to target specific research questions
best addressed by collaborative studies. In such projects, collection
and utilization of data need not be confined to the applicant Centers
but also could involve other Centers and other data sources. Applicants
will find on the NACC website the current directory of the Alzheimer's
Disease Centers as well as a description of the data collected at the
Centers. To initiate the process, potential applicants may contact the
NIA Program Officer listed below or the Director of NACC to determine
which Centers to contact to set up collaborations. Alternatively the
applicant may contact Centers directly to discuss potential
collaborations. Searches may be done on the entire database or on
individual datasets after approval for access has been granted. NACC
can use the MDS data to help applicants locate subjects with particular
characteristics for whom tissues and biological specimens may be
available at participating ADCs and will facilitate contact among
applicants responding to this RFA with the ADCs to locate information
and specimens for this project. Additionally NACC provides statistical
and epidemiological consulting concerning research questions, study
design and analytic methods best suited to the overall NACC database or
the individual Centers. Applicants should budget funds for NACC for
consulting and data management expenses.
Possible examples of scientific problems that could be addressed by
applications include but are not limited to collaborative projects
that:
o Study expression of Alzheimer's disease and other related dementias
in specific minority groups, in terms of clinicopathological
correlations, diagnostic issues, biomarkers, co-morbidities, particular
risk factors, differential prevalence, clinical presentation or course
of disease.
o Determine the impact of co-morbid pathological conditions (such as
diabetes; hypertension; heart disease; metabolic profiles) on normal
and abnormal cognitive brain aging, especially in relation to
vulnerable individuals, such as the oldest old.
o Study biological samples (blood, CSF, and other body fluids)
collected by standardized methods and currently stored at selected
Alzheimer's Disease Centers to get sufficient numbers of samples to
reach statistical significance; set up biochemical screens to identify
molecules indicative of disease state (protein, carbohydrate, and
lipid) and their relative concentration in serum, CSF, and other body
fluids in various subject populations. For example, protein identity
and concentration could be analyzed by proteomics methodologies, such
as MALDI-TOF, using biological samples from persons with 1) successful
aging, 2) normal aging, 3) mild cognitive impairment, 4) early stages
of AD, 5) late stages of AD, 6) AD with Lewy bodies, 7) AD with
cerebrovascular disease, 8) Parkinson's dementia, etc., at various ages
and degrees of disease progression. It may then be possible to identify
patterns or profiles of molecules that could be used to distinguish
among the various conditions and serve as biomarkers for preclinical
disease, diagnosis or disease progression.
o Characterize the pathological features (such as plaques, tangles,
Lewy bodies, cell death, synapse loss, atrophy, white matter lesions,
and micro infarcts), in different brain regions of selected individuals
to elucidate the temporal and spatial development of pathologies in
successful aging, normal aging, MCI, and early stages of AD.
o Identify the pathology or combination of pathologies that best
explains the neuropsychological deficits, if any, in individual
subjects.
o Determine whether any of the possible precursors of overt pathology
described below distinguish brains of persons with "normal" aging from
brains of persons who show subtle age-related cognitive changes often
preceding AD, from brains of persons with early AD. These changes could
include but are not limited to regional alterations in levels or
processing of tau or APP, changes in energy metabolism, oxidative
stress, calcium-regulatory mechanisms, inflammatory processes,
inappropriate neuronal entry into the cell cycle, altered metabolism or
degradation of proteins, axonal transport, or synaptic changes.
o Conduct microarray studies in specific brain regions and studies of
gene expression in single identified cells to illuminate the local and
widespread changes in gene expression that accompany successful aging,
normal aging, MCI, and the different stages of AD. Appropriately
characterized brains from persons who died with minimal agonal stress,
with relatively short postmortem intervals, and from whom brain RNA can
be analyzed quantitatively could be identified from Center resources
for such studies. Proposed studies could include appropriately
characterized brains of sufficient age ranges to allow for comparisons
from young to middle to old age, to characterize persons with MCI, or
pure AD pathology, etc. Microarray or cellular data generated from
these brain sets by different investigators and compiled into a
reference dataset would be one step towards identifying genomic
expression changes that consistently parallel age or disease
phenotypes.
o Investigate relationships between exposure to certain agents (such as
ACHE inhibitors, statins, antihypertensives, anti-inflammatories,
antioxidants or vitamins) and onset or progression of the disease.
o Study the incremental value of imaging on the clinical diagnosis of
AD and non-AD dementias.
o Investigate common mechanisms of disease pathogenesis in Alzheimer's
disease, Parkinson's disease, and Lewy Body disease, through clinico-
pathological correlations.
o Characterize the role and impact of different socio-cultural
environments in terms of risk of or protection from dementia.
o Evaluate caregiver characteristics and the dynamics underlying care
management across socio-economic groups, ethnicity, demographic
variables, and along the continuum of disease development and
progression.
o Define the disease-related and/or socio-cultural factors impacting on
consent to participate in clinical research, and testing of the
validity of various approaches to determine consent to clinical
research in different subgroups of patients in the Alzheimer's Disease
Centers.
o Utilize and/or collect data on behavioral components and psychiatric
symptoms associated with the development and progression of Alzheimer's
disease and other dementias such as vascular dementia, Parkinson's
dementia, Lewy body disease, and mixed dementia.
Applicants are encouraged to contact the Program Officers listed below
to clarify requirements and to discuss potential projects.
The National Institute of Mental Health
The National Institute of Mental Health (NIMH) also supports studies of
neurodegenerative diseases and special problems of the aging population
that are related to and affected by mental illness. For more
information on NIMH's late-life research program, please refer to
program announcement PA-03-014 Research on Mental Illnesses in Older
Adults (https://grants.nih.gov/grants/guide/pa-files/PA-03-014.html).
MECHANISM OF SUPPORT
This RFA will use the NIH R01 award mechanism. The total project
period for an application submitted for the R01 mechanism in response
to this RFA may not exceed five years. Applicants may request a budget
for direct costs of up to $300,000 per year, excluding F&A costs on
consortium arrangements, or up to $500,000 per year total costs. The
anticipated award date is September 2003.
FUNDS AVAILABLE
NIA has set aside funds sufficient to make at least three awards of up
to $500,000 per year (total cost). NINDS is setting aside funds to
make one award if the focus is on Parkinson's Disease and related
disorders and applicants utilize the resources of the Udall Centers.
Awards are contingent upon availability of funds and receipt of a
sufficient number of applications with outstanding scientific and
technical merit. This is a one-time solicitation.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
The Principal Investigator (PI) may be an Alzheimer's Disease Center or
Udall Center based senior investigator or a scientist outside the
Centers networks with demonstrated capability to organize, administer,
and direct collaborative, interdisciplinary research activities.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH
programs.
SPECIAL REQUIREMENTS
At least three Alzheimer's Disease Centers have to be involved in the
collaborative projects funded by NIA. Other Centers as well as
different data and specimen sources also may be utilized for data or
tissue collection. There must be a comprehensive collaborative
agreement among all participating entities that defines the
relationships among the PI, the participating Centers and other data
sources, and NACC. The PI must have a documented agreement and a plan
to subcontract with NACC and use NACC to manage data related to the
project. The participating Centers and other data sources must agree to
provide the data and/or samples necessary to complete the project
including the minimum data set for patients not enrolled in an ADC
Clinical Core. There should be clear agreement from all parties
regarding relationships, plans for interaction, details of data sharing
and mechanisms for transferring data to NACC. The letters of agreement
should be signed by an authorized individual at each participating site
and should accompany the application. Applications that at the time of
submission do not include within the application documentation of
collaboration with at least three ADC sites, Udall Center sites, if
appropriate, and NACC, will be returned without review.
There must also be a plan for sample utilization beyond that of the
initial application, including future access to data and samples. NIA
will evaluate the adequacy of the sharing plan before making funding
decisions. The PI should commit at least 10 percent effort to the
project, whereas participating investigators at the Centers should
commit at least 5 percent effort to this project. The application
should provide detailed information regarding procedures for obtaining
informed consent and adherence to local and state laws for surrogate
consent. Applicants should provide insurance of compliance with
relevant state and Federal regulations regarding confidentiality,
consent and sharing of human data and biological samples.
In order to assure active collaborations with the Alzheimer's Disease
and Udall Centers and NACC, all senior members of the collaborative
team in NIA-sponsored projects are expected to attend at least one of
the semi-annual meetings of the Alzheimer's Center Directors or in the
case of NINDS-sponsored projects, the annual Udall Centers meeting. The
cost of data transfer to NACC, data management and statistical
consulting by NACC, and travel for senior investigators to the Centers
meetings should be included in the proposed budget.
Sharing of Data and Biological Resources
Restricted availability of unique research resources, upon which
further studies are dependent, can impede the advancement of research.
The NIH is interested in ensuring that particular research resources
developed through grants become readily available to the broader
research community in a timely manner for further research,
development, and application, in the expectation that this will lead to
products and knowledge of benefit to the public health. Resources to
be shared will include appropriate data and biological samples
collected and all analysis techniques. Data sharing will be
accomplished through NACC.
To address this interest in assuring that research resources are
accessible, NIH requires applicants who respond to this RFA to submit a
plan for exercising intellectual property rights, should any be
generated through this grant, while making such research resources
available to the broader scientific community.
The sharing of research resources plan and intellectual property plan
must make unique research resources readily available for research
purposes to qualified individuals within the scientific community in
accordance with the NIH Grants Policy Statement
(https://grants.nih.gov/grants/policy/nihgps/) and the Principles and
Guidelines for Recipients of NIH Research Grants and Contracts on
Obtaining and Disseminating Biomedical Research Resources: Final
Notice, December 1999
(http://www.ott.nih.gov/policy/rt_guide_final.html) and
(http://ott.od.nih.gov/NewPages/64FR72090.pdf). These documents also
define terms, parties, responsibilities, prescribe the order of
disposition of rights, prescribe a chronology of reporting
requirements, and delineate the basis for and extent of government
actions to retain rights. Patent rights clauses may be found at 37 CFR
Part 401.14 and are accessible from the Interagency Edison web page,
http://www.iedison.gov.
NIH program staff will consider the adequacy of the plan and its
consistency with NIH and NIA/NINDS policies on data sharing and
intellectual property when determining whether to recommend an
application for award. The approved plan will become a condition of
the grant award and Progress Reports must contain information on
activities for the sharing of research resources and intellectual
property.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues, Alzheimer's
Centers and relationships with NACC to:
Creighton H. Phelps, Ph.D.
Program Director, Alzheimer's Disease Centers
Neuroscience and Neuropsychology of Aging
National Institute on Aging
Gateway Building, Suite 350
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: 301 496-1494
Email: phelpsc@nia.nih.gov
o Direct your questions regarding scientific/research issues,
Parkinson's disease and related disorders, and Udall Centers to:
Diane D. Murphy, Ph.D.
Program Director
Neurodegeneration Group
National Institute of Neurological Disorders and Stroke
NSC Rm 2223
6001 Executive Blvd.
Rockville, MD 20852
Telephone: 301-496-5680
FAX: 301-480-1080
Email: dm152o@nih.gov
o Direct your questions about peer review issues to:
Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging
Gateway Building, Room 2C212
Bethesda, MD 20892-9205
Telephone: (301) 496-9666
FAX: 301-402-0066
Email: NekolaM@nia.nih.gov
o Direct your questions about financial or grants management matters
to:
Deborah Stauffer
Lead Grants Management Specialist
Office of Grants and Contract Management
National Institute on Aging
Gateway Building, Room 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: 301-402-3672
Email: stauffed@nia.nih.gov
or
Kimberly Campbell
Grants Management Specialist
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd. Rm. 3249
Rockville, MD 20892
Telephone: (301) 496-7809
FAX: (301) 402-0219
Email: kc274k@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9666
FAX: 301-402-0066
Email: NekolaM@nia.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application
must be sent, along with all appendix materials, to:
Mary Nekola, Ph.D., Chief
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C212, MSC 9205
Bethesda, MD 20892-9205
APPLICATION PROCESSING: Applications must be received by the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an Introduction addressing
the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIA. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIA in accordance with the review criteria
stated below.
As part of the initial merit review, all applications will:
o Receive a written critique
o May undergo a process in which only those applications deemed to have
the highest scientific merit, generally the top half of the
applications under review, will be discussed and assigned a priority
score
o Receive a second level review by the National Advisory Council on
Aging or the National Advisory Neurological Disorders and Stroke
Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of your application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
The scientific review group will address and consider each of these
criteria in assigning your application's overall score, weighting them
as appropriate for each application. Your application does not need to
be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example,
you may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
(1) SIGNIFICANCE: Does your study address an important problem? If the
aims of your application are achieved, how do they advance scientific
knowledge? What will be the effect of these studies on the concepts or
methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Do you acknowledge potential problem areas and
consider alternative tactics?
(3) INNOVATION: Does your project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does your project
challenge existing paradigms or develop new methodologies or
technologies?
(4) INVESTIGATOR: Are you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to your
experience level as the principal investigator and to that of other
researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: The adequacy of the proposed protection for humans,
animals, or the environment, to the extent they may be adversely
affected by the project proposed in the application.
o INCLUSION: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), as appropriate
for the scientific goals of the research. Plans for the recruitment
and retention of subjects will also be evaluated. (See Inclusion
Criteria included in the section on Federal Citations, below)
o BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
o OTHER REVIEW CRITERIA:
The adequacy of documented agreements and a plan to subcontract with
NACC and use NACC to manage data related to the project.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 12, 2003
Application Receipt Date: March 12, 2003
Peer Review Date: Spring/Summer 2003
Council Review: September 2003
Earliest Anticipated Start Date: September 2003
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43).
All investigators proposing clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants are required to place data collected under this RFA in the
NACC, which can provide protections for the data and manage the
distribution for an indefinite period of time. The application should
include a description of the archiving plan in the study design and
include information about this in the budget justification section of
the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information
necessary to the review because reviewers are under no obligation to
view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet
site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.866 and 93.853, and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and administered under NIH grants policies described
at https://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.